Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

[1] – 9/19/2013 – “Americans love to fight, traditionally”

“All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players”

“Americans love a winner”

“Americans will not tolerate a loser”

– General George S. Patton, Jr., June.5, 1944

The above might as well be Greek to Dr. David H. Gorski a/k/a “Orac”

He’s the epitome of the word “loser”

Indeed, “Orac” described his work-place nemesis as “user hostile”

After 5 years, he still didn’t fully understand much of it, and he claims he’s not exactly computer illiterate

Gorski is that “guy” who couldn’t even find Burzynski’s publication:

[2] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer

[3] – “Orac” batted the big “O” when he tried to find “the scientific rationale to expect that” antineoplastons “might have antitumor activity”

[4] – Gorski was geniusless when it came to finding “which genes are targeted by antineoplastons,“ proving that he really does NOT know Burzynski’s personalized gene-targeted therapy

In fairness, I will point out that he hasn’t put the time in to learn all the ins and outs of the system …

He pontidefecates about phase II clinical trials when his name isn’t even on a phase 2 trial, too

[5] – 9/19/2013 – He’s the “guy” who’s “mystified” as to how Stanislaw Burzynski “has managed to keep practicing for 36 years after he first began treating patients with an unapproved (not ordinary) chemotherapeutic drug (the concoction of peptides purportedly isolated from blood and urine that Burzynski dubbed “antineoplastons” because of their alleged ability to inhibit the growth of cancer)”

This is not an issue unique to Gorski; I’ve discussed other cases like this, such as Bobby Blaskiewicz, who used his man-crush relationship with Gorski to appear on the Skeptic Canary Show; Davey James, who was only recently stripped of his license to practice in several states of mind; Adam Jacobs, who went so far as to use his business influence to alter his Dianthus Mediclueless web-site in London to be more hack friendly, and an interventist who administered twerkpidity to posers who didn’t have common sense and defrauded minions for tens of millions of minutia

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake

[6] – He has NOT yet figured out that Burzynski learned from the best

[7] – Who could do it better than someone like Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) who Burzynski had to deal with:

“This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded“

“However, your letter conspicuously fails to address them“

“You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false”

Pg. 2

“I am glad that you plan to “thoroughly examine the accusations” I have made”

“I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995”

After all, can we really take a person seriously, who claimed:
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[8] – 11/2/2012 – “Personally, having pored over Burzynski’s publications … “
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[9] – 5/8/2013 – “I’ve searched Burzynski’s publications … “
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[10] – 6/5/2013 – “ … I do know cancer science”
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Uhhhhhhh … yeah

But do you really know Burzynski’s cancer science when you did NOT even know:

“which genes are targeted by antineoplastons“?

Has “GOraCON” (“Orac” + @Gorskon) even read these ?
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[11] – 10/2003 – Waldbillig R, Burzynski SR. Mechanism of action, uptake, and gene array studies on the antineoplastic agent phenylacetylglutamine (PG) in human glioma cells U-87. Neuro-Oncology. 2003; 5: 309

Volume 5 Issue 4 October 2003

(genes CD38, OASL, and TCF8)
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[12] – 10/2007 – Patil, S., Burzynski, S.R., Mrowczynski, E., Grela, K. Phenylacetylglutamine (PG) and phenylacetate (PN) interact additively to produce detachment-induced apoptosis/anoikis in glioblastoma cells. Neuro-Oncology 2007; 9:482

Volume 9 Issue 4 October 2007

We have conducted a total human gene array screen using the Affymetrix Human Genome plus 2.0 oligonucleotide arrays, for genes regulated by PG and a combination of PG and PN

gene TXNIP was up-regulated almost 5-fold with PG, and almost 120-fold using a combination of PG and PN

genes that are significantly up-regulated are CLDND1, ATF3, CASP5, TP53, TRIB3, and UNC5B

Genes that were down-regulated include AKT2, ASPM, CDCA8

(caspase 5, p53, netrin receptor) and AKT pathway (AKT2, TRB3)
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[13] – 10/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. Antineoplaston AS2-1 affects cell cycle checkpoints, leading to apoptosis in human glioblastoma cells. Neuro-Oncology 2008; 10:786

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

CDCs 25A and 25B, cyclins D3 and E, and CDKs 3, 4, and 6

ORC1L and CDC6

MCMs 2, 3, 4, 5, 6, and 7, and CDC7

cyclins A, B1, and B2, polykinase 1, and CDKs 1 and 2

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

Based on pathway analysis, it was observed that anti-neoplastons affected the expression of more than 40 genes instrumental in the cell cycle in GBM cells
——————————————————————
[14] – 12/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008; 10:1148

Volume 10 Issue 6 December 2008

In 2004 the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma

12 FDA-supervised phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumors

A total human gene array screen using the Affymetrix Human Genome

The expression of mRNA for vitamin D3 up-regulated protein 1 (VDUP1) was found to be over 100 fold higher for cells treated with PG and PN

succinate dehydrogenase C (SDHC), fumarate hydrogenase (FH), succinate-CoA ligase 1 and 2 (SUCLG1and 2), and aconitase 2 (ACO2)
——————————————————————
[15] – 11/2010 – Patil S, Burzynski SR, Mrowczynski E, Grela K. Targeting MicroRNAs in Glioma Cells with Antineoplastons. Neuro-Oncology 2010; 12, iv10

Volume 12 Supplement 4 November 2010

This study was done using the Dharmacon mRNA profiling array (Thermo Fisher Scientific)

mRNAs 125a-5p and 125a-3p

mRNAs 125a-5p has recently been shown to be regulated by the epidermal growth factor receptor and to function as a tumor suppressor in lung cancer

It has also been shown that the over-expression of mRNA 125a or mRNA 125b caused reduced migration and invasion of SKBR3 breast cancer cells

Using the total human microarray screen (Affymetrix)

AKT2
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[16] – 6/2012 – Sonali, S. Patil, Stanislaw R. Burzynski, Emilia Mrowczynski, Krzysztof Grela, Sridar V. Chittur. Phenylacetylglutaminate and Phenylacetate in combination Upregulate VDUP1, cause cell cycle blockade and Apoptosis in U87 Glioblastoma cells. Journal of Cancer Therapy 2012;3:192-200
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[17] – 9/2012 – Patil, S., Burzynski S.R., Mrowczynski, E., Grela, K. P.003. Phenylacetylglutaminate in combination with Phenylbutyrate effectively inhibits growth of brain tumor cell In Vitro. Neuro-Oncology 2012;14(Suppl. 3):iii16

Volume 14 Supplement 3 September 2012

The FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of gliomas, in 2009

12 FDA-supervised Phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumor

AKT2

PG is not toxic to normal cells whereas PB has dose-limiting neuro-cortical toxicity
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Cancer care: Is the system “in crisis” ?

The Institute of Medicine, just in case you’re like “Orac” and have NOT yet figured it out, “the system” has been “in crisis” since the Gubment “forgot” who they are here to serve

[18] – Gorsi, maybe you can explain to The Institute of Medicine why the Cancer care system is “in crisis” because M.D.’s with Ph.D’s who hold positions “at an NCI-designated comprehensive cancer center,”are responsible for massive fact-checking #FAILS

What did you do, Gorski ?

Phone It in again ?
======================================
REFERENCES:
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[1] – 9/19/2013 – The Institute of Medicine report on cancer care: Is the system “in crisis” ?
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http://scienceblogs.com/insolence/2013/09/19/the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
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[2] – 1997 – Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/26/x/
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[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™
http://www.scienceblogs.com/Insolence
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/08/critiquing-dr-david-h-orac-gorski-and-the-skeptics/
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[4] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
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[5] – 9/19/2013 – Another case of the failure of physician regulation endangering patients
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http://scienceblogs.com/insolence/2013/09/19/another-case-of-the-failure-of-physician-regulation-endangering-patients/
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[6] – Critiquing: Dr. Michael A. Friedman, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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DID Dr. Michael A. Friedman FIB?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/18/did-dr-michael-a-friedman-fib/
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Dr. Michael A. Friedman, DATA ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/dr-michael-a-friedman-data/
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Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
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[8] – 11/.2/2012
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http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
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[9] – 5/8/2013
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http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
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[10] – 6/5/2013
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http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
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[11] – 10/2003
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Click to access 971.pdf

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[12] – 10/2007
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Click to access 5169.pdf

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[13] – 2008
——————————————————————

Click to access 7854.pdf

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[14] – 2008
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Click to access 7897.pdf

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[15] – 11/2010
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Click to access 8636.pdf

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[16] – 6/2012
——————————————————————

Click to access 9219.pdf

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Journal of Cancer Therapy, 2012, 3, 192-200
doi:10.4236/jct.2012.33028 Published Online June 2012
5. Acknowledgements
This study was supported by and carried out at the Burzynski research Institute (BRI), Houston TX, USA. The Microarray assay was supported by BRI and carried out at Center for Functional Genomics, University of Albany, NY, USA
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[17] – 9/2012
——————————————————————

Click to access 9291.pdf

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http://www.burzynskiclinic.com/scientific-publications.html
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[18] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
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Advertisement

Dr. Michael A. Friedman, DATA ?

[1] – 11/2/1993 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, which advised, in part, on page 1:

7. “In accordance with your letter we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated”

“The Theradex database is also available … “
——————————————————————
[1] – 11/2/1993 – This makes it clear that: “review of data” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[2] – 1995 (4/3/1995) – Dr. Mario Sznol, Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NIH), sent a 2 page letter for Dr. Michael A. Friedman, to Burzynski, in response to his letter of 3/29/1995, which advised, in part, on page 1:

“We will forward the data on the 1st 5 patients in a separate mailing as you requested”
——————————————————————
[2] – 4/3/1995 – This makes it clear that: “We will forward the data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[3] – 1995 (4/20/1995) – Burzynski sent a letter to Dr. Mario Sznol, Department of Health & Human Services (HHS), National Institutes of Health (NIH), in response to his letter of 4/3/1995, which advised, in part, on page 2:

“We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995″
——————————————————————
[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[4] – 1995 (5/16/1995) – Burzynski sent a letter to Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH), in response to his letter of 5/12/1995, which advised, in part, on page 2:

“I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995″
——————————————————————
[4] – 5/16/1995 – This makes it clear that: “I still have not received the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[5] – 1995 (6/6/1995) – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex“

(see 3/9/1994 letter)
——————————————————————
[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[6] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which he copied Dr. Michael A. Friedman on, which was in response to his letter of 7/21/1995, which advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data”

“Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[7] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons”

“Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:”

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[8] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“It is our understanding that NCI offered to allow Dr. Burzynski to participate in an interim and final meeting in which patient data from the study was to be reviewed”

“However, these meetings never took place because of the insufficient patient accrual and decision not to complete the study”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center”

“We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals”
——————————————————————
[8] – 10/5/1995 – This makes it clear that: “… these meetings never took place because of the insufficient patient accrual and decision not to complete the study”, is NOT Theradex, but the prior letters do NOT mention the word “MEETINGS”
=======================================
[1] – 11/2/1993 – This makes it clear that: “REVIEW OF DATA” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[2] – 4/3/1995 – This makes it clear that: “WE WILL FORWARD THE DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[4] – 5/16/1995 – This makes it clear that: “I STILL HAVE NOT RECEIVED THE complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

Why would you advise Burzynski:

[2] – 4/3/1995 – “WE WILL FORWARD THE DATA” if you had FORWARDED “THE DATA” since

[5] + [8] – the 7/18/1994 Theradex Clinical Studies Summary ?

Dr. Michael A. Friedman, DATA ?

Where is the DATA ?
=======================================

DID Dr. Michael A. Friedman FIB ?

[1] – 6/6/1995 – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies“

“2 patients were treated at the National Cancer Institute”

“Patient .26-77-03-9 … at the NCI“

“Patient .27-53-76-5 … “
——————————————————————
6/6/1995 we know “2 patients were treated at the National Cancer Institute” [1]

[2] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter; which he copied Dr. Michael A. Friedman on, to Burzynski’s attorney, Richard A. Jaffe, Esq., which was in response to his letter of 7/21/1995, and advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
6/6/1995 we know per Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanman [2]

[3] – 9/19/1995 – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995 letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons“

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute”[1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …”[3]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2]

[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

[4] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center“

“We have learned that 2 patients were enrolled … through the Clinical Center and hence … the Clinical Center … has medical records for those 2 individuals”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …” in his letter to Burzynski [3]

10/5/1995 we know that Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals”, in his letter [4]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2], and / or would have advised Burzynski in his 9/19/1995 letter that the National Cancer Institutes Clinical Center had “medical records for those 2 individuals” [3]

Dr. Michael A. Friedman

6/6/1995 you advised Burzynski that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 you were copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

8/23/1995 we know that you did NOT advise Burzynski that National Institutes of Health (NIH) Legal Advisor Robert B. Lanman’s written statement was NOT TRUE [2]

9/19/1995 you advised Burzynski that “We have no individual patient records in our possession …” [3]

10/5/1995 – Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals” [4]

Dr. Michael A. Friedman, I know that you would NOT break the law

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

Dr. Michael A. Friedman, please let me know why what you did was NOT a LIE

My primary obligation is to the American public, because, I know you would tell the TRUTH, since, in your words, you “could not responsibly act in any other manner”
======================================
[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
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[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[24] – 1995 (10/27/1995) – Burzynski 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)

I was shocked to read the Cancernet “fact sheet” the NCI has been distributing about the cancellation of the clinical trials of antineoplastons, the anti-cancer drugs I discovered and developed

I find it scandalous that a government agency is putting out a public document containing such blatantly false information

Let me remind you that the only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

NCI’s “fact sheet” tries to obscure that simple fact with misinformation such as the following:

“In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical response in a group of patients treated at Dr. Burzynski’s Houston facility

For this review, Dr. Burzynski selected from his entire clinical experience 7 brain tumor patients whom he felt had a beneficial effect from antineoplastons.”

This misstatement is obviously calculated to make the reader think that in my entire clinical experience I have had only 7 patients who benefitted from antineoplaston treatment, which is wildly untrue

In fact, I prepared not 7, but dozens of cases for the NCI reviewers

As you must know, the reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

Cancernet then compounds that misstatement with the following:

“This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available information, and included only cases selected by Dr. Burzynski” (my italics)

To the contrary, the patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

In fact, Michael Hawkins, M.D., leader of the site visit team, specifically complimented me on how complete and well-organized they were

The next misstatement is the following:

“The reviewers of this series determined that there was presumptive evidence of antitumor activity . . .”

Pg. 2

Now that the NCI’s Cancer Therapy Evaluation Program (CTEP) is under fire for misconduct in these clinical trials, it is rewriting history

The statement of the NCI scientists who actually reviewed patient records was quite different from the above

Their report (minutes of Decision Network committee meeting enclosed) stated that “The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate” (my italics)

In other words, according to the site visit team, there was no question that the treatment worked in the cases reviewed

All that remained to be determined were the numerator and the denominator

Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, (enclosed), states that

“The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred” (my italics)

But by far the most outrageous misstatement is the following:

“On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes to the protocol to increase accrual, and there was no hope of completing the studies in a timely manner.”

The NCI never made any effort to “reach a consensus.”

Instead, it simply violated the written protocol we had agreed upon

Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases

in other words, NCI was accepting patients whose brains and spinal cords were literally consumed by large malignant tumors–patients so advanced as to have no chance whatsoever

When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it

The above is all well documented

While we were still in the negotiating stages, Michael Friedman, M.D. of the NCI wrote me a letter dated 11/2/1993 (enclosed) “. . . we will accede to all the modifications that you have stipulated.”

Dr. Friedman specifically agreed to exclude patients with:

* tumors larger than 5 cm (2 inches)
* multiple tumors
* metastases to spinal cord
* Karnofsky performance scores less than 70%

Based on Dr. Friedman’s written assurance that NCI would honor this exclusion criteria, I provided NCI with a large quantity of antineoplastons, and the clinical trial began

on 3/23/1994, Mario Sznol, M.D., of NCI wrote me proposing that NCI drop the exclusion for multiple tumors and spinal cord metastases, increase the maximum tumor size from 5 cm to 8 cm, and lower the Karnofsky score from 70 to 60 (enclosed)

in a response dated 4/19/1994 (enclosed), I wrote back that I would be glad to help NCI design a separate trial for such advanced patients, using a more aggressive dosage schedule

But I made it clear that it would be unethical to use the current dosage schedule on such patients since my experience had shown that such patients do not respond well to it

Pg. 3

As proof , I pointed out that in the NCI’s own review of patients treated with antineoplastons, the only ones who had less than 50% tumor shrinkage were exactly those with tumors greater than 5 cm

I did not hear back from NCI and assumed the matter had been dropped

Nearly one year later–in 3/1995–I learned that NCI had made all the changes to which I had objected

In fact, NCI went even further

Rather than raising the maximum tumor size from 5 to 8 cm as the NCI earlier suggested, it began accepting patients with any size tumor

I insisted that NCI either honor our agreement or change the Informed Consent statement (which patients must read and sign) to reflect the fact that I, the drug’s discoverer and developer, felt that the treatment was unlikely to be effective in such advanced patients in the doses being used

Rather than honor it’s commitment to conduct the study as agreed, NCI cancelled it

I find it particularly curious that now neither NCI nor Memorial Sloan-Kettering Cancer Center (MSK) will take responsibility for changing the exclusion criteria, and are instead pointing fingers at each other

in his letter of 4/3/1995 (enclosed), Dr. Sznol repeatedly refers to the “revised” eligibility criteria proposed by the [Memorial Sloan-Kettering] investigators” (my italics)

But, in a letter to John Lewis, M.D., of Memorial Sloan-Kettering’s Institutional Review Board dated 1/31/1995 (enclosed), the Chief Investigator, MSK’s Mark Malkin, M.D., writes that

“Further amendments, as described below, have been made at the request of NCI” (my italics)

If the changes to the protocol are as the NCI would have the world believe, why is everyone connected to them scurrying to disavow responsibility?

An even more serious matter is what appears to be the investigator’s relentless violations of the treatment protocol

Looking at the treatment summaries compiled by Theradex Corporation, the medical reporting company hired by NCI to compile and tabulate patient treatment data, it would appear that investigators violated the agreed-upon protocol in every patient treated

Apparent violations include the removal of patients from treatment who had no tumor growth (including one patient who, during subsequent surgery, was found to have no cancer cells remaining), and the removal of a patient for “skin reactions” caused not by antineoplastons, but by another drug patient was receiving, DPH

This is clear due to the fact that the patient’s skin condition worsened when he was taken off antineoplastons

It improved only after DPH was discontinued

The summaries provided by Theradex are somewhat sketchy, so I asked to review the complete records of patients tested–which Dr. Friedman had specifically promised to provide

NIH lawyer Robert Lanman replied in a letter dated 8/23/1995 (enclosed) that the NCI did not have any such records

In fact, several patients were treated at NCI and of course NCI has their complete medical records

When I demonstrated this by sending Mr. Lanman copies of patient records obtained by a patient’s family from NCI, he admitted in fact NCI does have patient records, but refused to release them

And he disregarded his own misstatements of fact by saying that

“Given that you apparently have already obtained at least one of the patient’s records, we fail to understand why you are perusing this matter” (letter from Robert Lanman dated 10/5/1995 enclosed)

Mr. Lanman also claims that NCI has “no such commitment” to release medical records of patients treated with antineoplastons

And Dr. Friedman, in a letter dated 9/19/1995 (enclosed), writes that Dr. Burzynski’s request for “detailed records” has been satisfied by the sketchy Theradex treatment summaries

Pg. 4

Both these statements directly contradict Dr. Friedman’s letter of 11/2/1993 (enclosed), in which he promises that

“In accordance with your letter, we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated

This should be sufficient to assure that the conduct of the study is satisfactory

The Theradex database is also available . . .” (my italics)

In other words, Dr. Friedman promised to provide me with patient medical records, recognizing that the Theradex summaries are something quite separate

In that same 9/19/1995 letter, Dr. Friedman writes that

“We have no individual patient records in our possession in addition to the Theradex reports.”

Either he is deliberately misstating the facts, or he is out of touch with the Cancer Therapy Evaluation Program that he runs

Dr. Klausner, I request that you immediately withdraw the “fact sheet” the NCI is distributing which contains numerous and outrageous misstatements and distortion of fact

Thank you for your attention to this matter

SRB/cf

cc:

3+ pgs cc:
——————————————————————

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1993 (11/2/1993) – Dr. Michael Friedman to Burzynski
1994 (2/17/1994) – NCI “fact sheet”
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol
1995 (1/31/1995) – Dr. John L. Lewis
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
1995 (8/18/1995) –
1995 (8/23/1995) – Robert B. Lanman to Burzynski
1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski
1995 (10/5/1995) – Robert B. Lanman to Burzynski
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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 2 page letter to Burzynski

I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:

Date Report

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

I am enclosing a summary of the categories of data that are included in the reports you have received

These reports are the same ones that have been provided to us by the contractor during the conduct of the Antineoplaston studies

Both the format and frequency of these reports are routine for reporting data of ongoing NCI Phase II trials to the Cancer Therapy Evaluation Program staff

These are also the same types of reports that are provided to pharmaceutical companies when they are cosponsors of a study

We have no individual patient records in our possession in addition to the Theradex reports

As of the last report provided to you of 4/10/1995, prior to the studies being put on hold and subsequently closed, you were sent the same reports that were provided to CTEP staff and protocols T93-0078 and T93-0134

However, enclosed for your convenience is a recent print-out of the data that was prepared for our staff in a slightly different format

Once the routine quality control review of data entry has been completed, we will send you a final print-out
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1995 (9/19/1995) – Friedman to Burzynski [18]
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[21] – 1995 (8/23/1995) – Robert B. Lanman to Burzynski (1 Pg.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[21] – 1995 (8/23/1995) – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division 1 page letter to Richard A. Jaffe, Esq.

This is in response to the issues raised in your 7/21/1995 letter

First, you raised questions as to how clinical trials of antineoplastons could proceed absent Dr. Burzynski’s concurrence

Although NCI clearly prefers to conduct or sponsor studies with permission of such an individual is not required

In the present case, even assuming that the clinical trials involved some of Dr. Burzynski’s patented products or processes, the use of antineoplastons would be permissible under the research exemption

However, in light of the recent decision to close the studies at the Mayo Clinic and Memorial Sloan-Kettering, conveyed to Dr. Burzynski in a letter from Dr. Michael A. Friedman dated 8/18/1995, these issues now seem moot

In addition, you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators

To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data

Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)

The NCI does not possess any individual patient records to provide to Dr. Burzynski

Finally, we are not aware of any “committee” investigating Dr. Burzynski’s allegations regarding the protocols

cc:

M. Friedman, M.D.
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1995 (8/23/1995) – Robert B. Lanman to Richard A. Jaffe [17]
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[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.)
——————————————————————
Michael A. Friedman, M.D., Associate Director,Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, National Institutes of Health

Dear Dr. Friedman,

It has been brought to my attention that the protocol

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced Recurrent Malignant Astrocytomas”

has been amended to accept patients with tumors measuring over 5 cm in diameter, multiple tumors, or with leptomeningeal or systemic metastases

Another change involves lowering of the Karnofsky Performance Status score to 60%

You assured me in your letter of 11/2/1993 that

“The dose and schedule will be modified exactly as you require”

and

“The eligibility criteria will be modified to accept only patients with Karnofsky Performance Status of 70% – 100%

I am outraged that without my knowledge Memorial Sloan-Kettering Cancer Center with NCI’s permission changed the protocol

Treatment of patients with tumors larger than 5 cm, with multiple tumors, and leptomeningeal spread or distant metastases will require a different protocol with a different schedule and different dosages

the use of the existing protocol for such very advanced brain tumor patients will only expose them to unnecessary risks without giving them substantial benefit

I hereby request that the amendments described above be cancelled immediately and the original protocol be used for the treatment as promised in your letter of 11/2/1993

We will be glad to propose a different protocol for patients with larger and multiple tumors and meningeal involvement

In addition, the procedure we agreed upon calls for a thorough review by us of the 1st 5 patients as soon as they are accrued

Your last annual report indicates

Pg. 2

that you had accrued that number of patients 6 months ago

As a result, the review of data is long overdue

Please send us the complete records of the 1st 5 patients so that we may review them as specified

Please do not accrue any more patients until this data has been sent and our review completed

SRB/cf

cc:

Dr. Jan Bruckner
Dr. Michael C. Christian
Dr. Jay Greenblatt
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
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1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
——————————————————————
Dear Dr. Friedman,

In response to your letter of 10/20/1993, it is difficult for me to understand why the entire 1st page of your letter is used to discuss the simplest issue:

that adults should use a different dosage than that used for children

Since you agreed to the study procedure of Protocol BT-6 as recommended in my letter of 6/9/1993, we have not requested any changes in the structure of treatment which was accepted by Memorial-Sloan-Kettering Cancer Center (MSKCC)

As you confirmed in your letter of 10/20/1993, you know very well that since 4/1/1993 of this year my recommended dosage of Antineoplaston AS2-1 for adults is 0.4g/kg/24h

Again, I confirmed that this is the right dosage for adults in my letter to Dr. Shoemaker of 8/24/1993

Yet, for no apparent reason, you insist on using in the adult treatment protocol the dosage 0.6g/kg/24h which I recommend for children

It is generally known that a child’s body weight is much lower than that of adults

This should be reflected in the escalation of the dosages

My recommendation as to how to escalate the dosages for adults was submitted to the NCI on 6/4/1992

Yet, for no apparent reason the MSKCC protocol, which is designed for adults, escalates the dosages in the small increments recommended for children

The principle behind dose escalation is to accomplish the maximum dosage in 3 to 5 days, not 3 to 4 weeks, which would expose the patient to the unnecessary risk of tumor progression

I appreciate very much that you have finally decided to follow my recommendation regarding dosage and dosage escalation

Regarding the number of patients to be treated at MSKCC, the contradictory, incomplete, and inconsistent information is being supplied by you

The MSKCC’s protocol of 4/16/1993, 7/13/1993, and 8/30/1993 describe the treatment of 35,

Pg. 2

but not 70 patients

(please see paragraph 12.1, pg. 10 of the protocol, which is attached)

It was our understanding that 35 patients would be treated at MSKCC and at the Mayo Clinic

I never agreed for the treatment of 70 patients at MSKCC

Since I have to produce the medicine for the trial and pay for it, it is vitally important to me to know how many patients will be treated

The treatment of an additional 35 patients may cost up to 2 million dollars

Contrary to the information given by NCI that we received the money for the production of medicine, this money went apparently into a “black hole”

(“Black Holism,” The Village Voice, 7/29/1993, enclosed)

We have received none of the money which the Office of Alternative Medicine gave to the NCI for funding the trials with our medicine

Contrary to the opinion expressed in your letter, we see no reason for modifying Fleming’s Phase II clinical trial design and introducing more stringent than usual criteria for response evaluation

We request that Fleming’s original design be used, which calls for the initial treatment of 15 patients with at least one responder, instead of 20 patients and 2 responders

Given the fact that there is no existing treatment effective in this type of cancer, one responder in 15 is certainly significant and would be reason enough to expand the trial

I found your your requirement for 14 days to complete scans and laboratory tests prior to treatment very interesting

It is a very well known fact that glioblastoma multiforme is such an active tumor that if 2 weeks elapses from the time of the scan and the beginning of treatment, the tumor may increase by more than 50%

This means that even before the patient begins treatment, he can be classified as an increasing disease case

In most of the hospitals in the U.S., including out tiny clinic, all pretreatment tests including the scans can be done in one day

Therefore, I insist that the pretreatment evaluation, including brain scans, be done within 7 days from the time treatment begins

Regarding the Karnofsky Performance Status (PS), it is unclear to me why you have backed off from your own recommendation in your letter of 5/5/1993 (copy attached) that “patients with Karnofsky PS of below 70% should be excluded”

I am requesting that as recommended by NCI, the patient’s PS should be 70% to 100%

I agree that both scan data and neurological assessment can be described in the analysis of response, but the decision of how to classify response should be based on tumor measurements alone

All of these patients will have been extensively treated before

As the result of previous neurotoxic treatments, a number of these patients will deteriorate neurologically even if the Antineoplastons eradicate the

Pg. 3

tumor

The purpose of the protocol is to evaluate the antitumor effect, not to prove that Antineoplastons can repair brain damage resulting from chemotherapy and radiation

In this 1st independent study with Antineoplastons, in order to assure that patients will derive the most benefit from the treatment, it is critically important to schedule more frequent evaluations of the data than waiting until after the accrual of 14 patients, i.e. waiting 9 months

(Based on an accrual of 2 patients per month, if we wait until 14 patients are accrued and treated, 9 months will pass before the 1st evaluation takes place)

Therefore, I request that reviews of the studies be performed after the treatment of each group of 5 patients, i.e. after 6 months

I agree, however, that you will provide the Theradex printout to us as you receive it

In addition to patient welfare, there is another reason for more frequent patient evaluations

As you stated in your letter, I have no doubt that the investigators at MSKCC have extensive experience treating glioma

However, MSKCC is known to be biased against Antineoplastons

At least 3 researchers associated with MSKCC published willful misrepresentations and distortions about Antineoplaston research

Because of the controversial nature of the upcoming Antineoplaston clinical trials, it is essential that they are conducted in a manner beyond any suspicion of bias

Contrary to the opinion expressed in your letter, NCI is responsible for the trial’s delay

As you well know, the NCI selected an MSKCC investigator in 9/1992

In spite of our repeated requests, 8 months were waisted before the NCI produced the 1st draft of the protocol

As promised in my letter to you of 11/11/1992, the supply of Antineoplastons has been prepared and was shown to Ms. Mary McCabe of NCI during the site visit on 2/9/1993

The medicine was ready to be released pending final approval approval of the labels by the FDA and our final QC inspection

The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested

Since you mentioned that patient recruitment has begun already, I would be glad to accept these patients immediately under my care and offer them free medicine as we wait for the protocol to be revised and the treatment at MSKCC to begin

The MSKCC protocol in its current form would threaten the welfare of these patients

In your letter you stated that your mission is to find and develop better therapies for cancer patients, and that your only obligation is to those patients

However, the way

Pg. 4

you proceed leads me to question that for the following reasons:

1) Out of numerous cancer treatment centers, you selected 2:

MSKCC and Mayo Clinic, which are known to be strongly biased against alternative treatments

In the past doctors associated with MSKCC have voiced strong opposition to Antineoplaston therapy and have published articles full of misrepresentations and distortions

2) The protocol approved by you will allow the disease to progress between the pretreatment evaluation and the beginning of treatment

3) Due to the slow escalation of dosages, patients will most likely have marked increase of tumor size beginning the treatment at the correct dosage level

4) In spite of my numerous requests (letters of 4/29/1993, 6/9/1993, and 8/24/1993) to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991 to have a separate clinical trial for glioblastoma multiforme and anaplastic astrocytoma, you continue to combine both types of tumors together

Even in your most recent stratification strategy submitted to the FDA, you are planning to treat initially 20 patients without specifying whether those 20 patients are per each stratum (glioblastoma vs. anaplastic astrocytoma), or whether this initial group of 20 patients consist of a mixture of glioblastoma and anaplastic astrocytoma

If the latter is the case, then we can expect that among these 1st 20 patients, most will have glioblastoma, which is more common and more difficult to treat

In case of treatment failure in these 20 patients, it will be easy to make the statement that Antineoplastons do not have therapeutic effect in both tumor categories

5) The protocol now states in paragraph 10.2, 10.3, and 10.4 that the objective decrease of tumor size is not enough to be considered a true response to treatment, that there must also be improvement in neurological function

As I explained in my letter of 10/13/1993 to Dr. Greenblatt, it is not unusual in my practice to see patients whose tumor has disappeared, but who have deteriorated neurologically as the result of delayed toxicity from radiation therapy and chemotherapy

Since these patients in the MSKCC study have been pretreated, and since there has been no indication that anything, including Antineoplastons, can repair brain damage caused by chemotherapy and radiation, I request that the criteria including restored neurological functioning be removed from paragraphs 10.2, 10.3, and 10.4 of the protocol

Pg, 5

6) Finally, by limiting our access to the data and not allowing review until after the 1st 14 patients have been treated, it would be easy to deviate from the protocol and supply inadequate treatment, and then claim that due to the the failure of the 1st 14 patients it would be a waste of the taxpayers money to proceed with further treatment

Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise

It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders

Once again, I urge you to take our requests seriously, honor the guidelines of the NCI’s Decision Network on 12/2/1991, and make proper corrections to the protocol, so that objective clinical studies can begin immediately

In the meantime, I would be glad to treat for free all the patients presently recruited, and will submit progress reports weekly for the NCI’s review and evaluation

SRB/cf

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Dianne Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Daniel Eskinazi
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
======================================

======================================
1993 (10/26/1993) – SRB to [5]
1993 (10/26/1993) – SRB to [14]
1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 Pgs.]
1992 (6/4/1992) Burzynski to NCI
1992 (9/1992) – NCI selected MSKCC investigator
1992 (11/11/1992) – Burzynski to Dr. Michael A. Friedman
1993 (2/9/1993) – NCI Mary McCabe site visit
1993 (4/1/1993) –
1993 (4/16/1993) – MSKCC protocol
1993 (4/29/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (5/5/1993) – Dr. Michael A. Friedman to Burzynski
1993 (6/9/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (7/13/1993) – MSKCC protocol
1993 (7/29/1993) – “Black Holism,” The Village Voice
1993 (8/24/1993) – Burzynski to Dr. Dale Shoemaker
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (8/30/1993) – MSKCC protocol
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski
======================================

[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment, National Cancer Institute (NCI), Department of Health & Human Services (HHS), National Institutes of Health (NIH) letter to Burzynski [4 Pgs.]

Dear Dr. Burzynski:

This letter is in response to your correspondence of 10/11/1993

(addressed to Dr. Sznol)

and of 10/13/1993

(to Dr. Greenblatt)

Your most recent comments regarding the approved study of antineoplastons in adults brain tumor patients, faxed to Dr. Greenblatt on 10/13/1993, come as quite a surprise

Particularly confusing are your comments regarding dose and schedule of antineoplastons proposed in that study (your comment #1)

Originally the dosage and schedule for this study was based on your protocol BT4

This version of BT4 was entitled,
“Therapy of high-grade glioma with continuous infusions of antineoplastons A10 and AS2-1”,
and was accompanied by 12 case histories

(patients with either anaplastic astrocytoma or glioblastoma multiforme treated apparently according to BT4)

In your letter of 4/26/1993, however you stated that protocol BT4 was only for low-grade gliomas

Furthermore, you noted that protocols BT5 or BT6 should be used for patients with anaplastic astrocytoma and gliobastoma multiforme

In that same letter (4/20/1993), you noted that AS 2-1 was tolerated well at doses of .5 gm/kg/24h by adult patients when administered in intermittent injections (this is method of administration in BT6 and in the IND study)

You stated that if given by continuous infusion, adults would experience increased sleepiness and tiredness, and specifically stated that the dosage of AS2-1 by continuous infusion for low-grade gliomas should be reduced to 0.4 g/kg/24h

You did not provide data to support these assertions, nevertheless, based on these comments and our review of the protocols BT4, BT5, BT6, we instructed the investigators to revise their protocol in accordance with your instructions

In the Consensus Review sent 5/5/1993, we instructed the Memorial Sloan Kettering investigators to pattern their protocol according to BT5, which was written for both children and adults
We specifically pointed out that BT6 was written for children

In your letter of 6/9/1993, regarding our Consensus Review, you specifically asked that the investigators use the treatment program according to BT6, knowing that the Memorial protocol was for adults with AA and/or GM

You did not at any time mention that dose escalation should be modified for adults, or mention any dose limitation for adults given the intermittent as specified in the BT6 protocol

Page 2

Your concerns regarding dose limitation in the previous letter appeared to be related to continuous infusion administration

The letter of 6/9/1993, contained only 4 comments and at that time you had both the protocol and Consensus Review in your possession

We transmitted your letter of 6/9 directly to the investigators, and all your requested changes were made

Our sincere efforts to attempt to duplicate your findings and follow your recommendations are frustrated by receiving contradictory, incomplete, and inconsistent information from you

We have, at multiple points in the protocol development, solicited your input and followed your guidance in getting recommended dose escalation and modification guidelines for adults

Please note that, one last time, we will ask the investigator to revise the protocol with regard to dose and schedule in compliance with your latest letter

However, we plan that the study will begin immediately and this will be the last such modification

Although you have not provided data to support each of your specific recommendation, we have incorporated them

With regard to comment #2 of your Fax of 10/13/1993, you have misinterpreted the protocol

The total number of potential patients is 35/stratum, (ie a total of 70 patients) allowing for an adequate Phase II evaluation of each group of patients

With regard to the statistical section, your #3 comment, there is little reason to assume that the modified Fleming design currently used in the protocol for the first stage of accrual is less appropriate than a design using 15 patients in the first stage

If the true response rate of the antineoplastons is 20% (standard criteria for activity in all our phase II trials considered worthy of further study), the chance of proceeding to the second stage of accrual with the current design is 93.1%

The chance of proceeding to the second stage using 15 patients in the first stage of accrual is 96.5%

These differences are not considered meaningful

With regard to your comment #4, we wish to maintain the standard clinical trials methodology used to evaluate new agents

We know of no evidence that obtaining a brain scan within 7 days of treatment versus within 14 days of treatment will in any way affect the evaluation of activity of a drug in this disease

The protocol clearly states that scans must be obtained within 2 weeks of study entry

Please also note that the practical difficulties in scheduling scans and completing the pretreatment work-up in just one week; the costs of repeating tests simply to meet this artificial deadline could not be justified and probably would not be covered by insurance companies

With regard to your point #5, (performance status) your own protocols allow patients with Karnofsky performance status of 60

We see no reason to demand a more stringent entry criteria for performance status than you have employed for your own patients

Page 3

With regard to your point #6, the use of neurologic status as well as CT scans/MRI findings to determine response, this was suggested to the investigators in our Consensus Review of 5/5/1993

You made no comment regarding this in your letter of 6/9/1993

This use of neurologic function as an additional criteria to determine response is an objective measurement and is standard among protocols we sponsor for glioma patients . .

It is scientifically acceptable to include the criteria for response as currently written in the protocol

At analysis, both scan data and objective neurologic assessment can be described

With regard to your letter of 10/11/1993, concerning data reviews, we are satisfied that reviewing the data after accrual of the first 14 patients/stratum is sufficient

We share your concerns about patient safety but believe that these investigators have extensive experience treating glioma patients, are superb and careful physicians, and have extensive experience administrating a range of investigational agents to these patients

Furthermore, the patients will be followed carefully, and dose reductions for expected toxicities will be carried out as specified in the protocol

Nevertheless, your experience with the agents is valuable and the availability of your guidance is much appreciated

If necessary, we will arrange a conference call at the end of treatment of the first 5 patients, or sooner if problems occur

Your participation in such a conference call, if necessary, would be welcome

We will provide the Theradex (CTMS) printout to you on a monthly basis as we receive it

We do not believe it is practical or necessary to supply data on an every 2 week basis

The most important unresolved issue at this time is that we are still waiting to receive the promised supply of antineoplastons to conduct these studies

Your letter of 11/5/1992, guaranteed a supply of the antineoplastons by 3/31/1993

(see attached)

As of today we still have not received it

Believing that you would be shipping drug to the NCI, and since the protocol is approved at Memorial Sloan Kettering, recruitment of patients has begun

As you point out, these patients have aggressive disease, and cannot afford to wait to begin treatment

We are prepared to try to assist you in meeting this commitment, but we know of no obstacle here at NCI

We urgently request, again, that you ship the drug immediately

Please be aware that our mission is to find and develop better therapies for cancer patients, and our only obligation is to those patients

Our agreement to pursue these studies with antineoplastons was based on suggestive evidence

Page 4

of activity noted in your best case studies

If you are unable or unwilling to provide the antineoplastons in the near future, we will pursue alternative sources to procure the drug or its active components, and will proceed with a clinical development plan to determine whether these chemicals have activity and are beneficial for patients

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, Department of Health and Human Services, National Institutes of Health

cc:

Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Jay Grabnett
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
——————————————————————

======================================
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski [8]
1992 (11/5/1992) – Burzynski ANP 3/31/1993
1993 (4/20/1993) – Burzynski (4/26/1993)? in that same letter
1993 (4/26/1993) – Burzynski
1993 (5/5/1993) – Consensus Review
1993 (6/9/1993) – Burzynski re Consensus Review
1993 (10/11/1993) – Burzynski to Dr. Mario Sznol
1993 (10/13/1993) – Burzynski fax to Dr. Jay Greenblatt
======================================

[4] – 1991 (10/31/1991) – Dr. Michael A. Friedman Memorandum to Dr. Bruce A. Chabner (1 pg.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[4] – 1991 (10/31/1991) – Dr. Michael A. Friedman Memorandum to Dr. Bruce A. Chabner (1 pg.)
——————————————————————
Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI)

Memorandum

(Unconventional Therapy File. – written in)

Subject: Antineoplastons

To: Bruce A. Chabner, M.D.
Director, Division of Cancer Treatment

I thought you would be interested in this for several reasons:

1. Our Unconventional Cancer Treatment approach seems to be working well (thanks to Mike Hawkins).

2. Our on-site review process is working well (thanks to Dorothy Macfarlane)

3. Antineoplastons deserve a closer look

It turns out that the agents are well defined, pure chemical entities

They are relatives of Thalidomide with presumed good CNS penetration

We are working with DTEP on them

The human brain tumor responses are real

We will keep you informed

(Mike Why not test These in a phase II trial – written in)